Hannover Medical School, University Eye Hospital, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
BMC Ophthalmol. 2020 Mar 30;20(1):122. doi: 10.1186/s12886-020-01397-x.
Intravitreal injections are a mandatory treatment for macular edema due to nAMD, DME and RVO. These chronic diseases usually need chronic treatment using intravitreal injections with anti-VEGF agents. Thus, many trials were performed to define the best treatment interval using pro re nata regimes (PRN), fixed regimes or treat-and-extend regimes (TE). However, real-world studies reveal a high rate of losing patients within a 2-year interval of treatment observation causing worse results. In this study we analyzed retrospectively 2 years of real-world experience with an individualized treat-and-extend injection scheme.
Since 2015 our treatment scheme for intravitreal injections has been switched from PRN to TE. Out of 102 patients 59 completed a follow up time of 2 years. Every patient received visual acuity testing, SD-OCT and slit lamp examination prior to every injection. At each visit an injection was performed and the treatment interval was adjusted mainly on SD-OCT based morphologic changes by increasing or reducing in 2-week steps. Individual changes of the treatment protocol by face-to-face communication between physician and patient were possible.
After 1 year of treatment visual acuity gain in nAMD was 7.4 ± 2.2 ETDRS letters (n = 34; injection frequency: 7.4 ± 0.4) respectively 6.1 ± 4.7 in DME (n = 9; injection frequency: 8.4 ± 1.1) and 9.7 ± 4.5 in RVO (n = 16; injection frequency: 7.6 ± 0.5). After 2 years of treatment results were as following: nAMD: visual acuity gain 6.9 ± 2.1 (injection frequency: 12.6 ± 0.7); DME: 11.1 ± 5.1 (injection frequency: 14.0 ± 1.0); RVO: 7.5 ± 5.0 (injection frequency: 11.2 ± 0.9). Planned treatment exit after 2 year was achieved in 29.4% of patients in nAMD (0% after 1 year); 0% in DME (0% after 1 year); and 31.3% in RVO (0% after 1 year). Patients' persistence was 94.1% during the follow-up.
Using a consequent and individualized TE regime in daily practice may lead to a high patients' persistence and visual acuity gains nearly comparable to those of large prospective clinical trials. Crucial factors are face-to-face communication with the patient as well as a stringent management regime. At this time TE may be the only instrument for proactive therapy which should therefore be regarded as a first-line tool in daily practice.
玻璃体内注射是治疗 nAMD、DME 和 RVO 所致黄斑水肿的强制性治疗方法。这些慢性病通常需要使用抗 VEGF 药物进行玻璃体内注射的慢性治疗。因此,许多试验旨在通过定期给药方案(PRN)、固定方案或治疗-延长方案(TE)来确定最佳治疗间隔。然而,真实世界的研究显示,在 2 年的治疗观察期内,有很高的患者失访率,导致结果更差。在这项研究中,我们回顾性分析了 2 年的真实世界使用个体化 TE 注射方案的经验。
自 2015 年以来,我们的玻璃体内注射治疗方案已从 PRN 转为 TE。102 例患者中,59 例完成了 2 年的随访。每位患者在每次注射前均进行视力测试、SD-OCT 和裂隙灯检查。每次就诊时,根据 SD-OCT 上的形态学变化,通过增加或减少 2 周的步骤来进行注射,并调整治疗间隔。通过医生和患者之间的面对面沟通,可以对治疗方案进行个别调整。
治疗 1 年后,nAMD 的视力提高了 7.4±2.2 ETDRS 字母(n=34;注射频率:7.4±0.4),DME 为 6.1±4.7(n=9;注射频率:8.4±1.1),RVO 为 9.7±4.5(n=16;注射频率:7.6±0.5)。治疗 2 年后的结果如下:nAMD:视力提高 6.9±2.1(注射频率:12.6±0.7);DME:11.1±5.1(注射频率:14.0±1.0);RVO:7.5±5.0(注射频率:11.2±0.9)。计划在第 2 年退出治疗的患者在 nAMD 中达到 29.4%(第 1 年为 0%);DME 中为 0%(第 1 年为 0%);RVO 中为 31.3%(第 1 年为 0%)。在整个随访期间,患者的依从性为 94.1%。
在日常实践中使用一致的个体化 TE 方案可能会导致患者的高依从性和视力提高,几乎与大型前瞻性临床试验相当。关键因素是与患者进行面对面沟通以及严格的管理方案。目前,TE 可能是主动治疗的唯一手段,因此应将其视为日常实践中的一线工具。